Kornimate/medical-research-clean huggingface dataset:
pilot study of a pharmacy intervention for older adults with cancer

Conditions: Breast Cancer; Lung Cancer; GI Cancer

Summary: the purpose of this research study is to address the challenge of medication management for older patients undergoing treatment for cancer. the sponsor of this protocol is the massachusetts general hospital cancer center who is providing funding for this research study.

the goals of the proposed study are: (1) to demonstrate the feasibility and acceptability of delivering prime (pharmacist reconciliation to improve medication management in the elderly) to older patients with breast, gastrointestinal, and lung cancers; and (2) to estimate the effect size (i.e. the magnitude of the difference between groups) of prime for improving medication management (e.g. accurate medication list, less polypharmacy, fewer potentially inappropriate medications) and achieving up-to-date vaccinations.

Eligibility criteria:
inclusion criteria: * age 65 or older * diagnosed with any stage breast, gi or lung cancer * panning to receive first-line chemotherapy at mgh * verbal fluency in english exclusion criteria: * unwilling or unable to participate in the study * significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study

Keywords: cancer care
endovascular treatment of peripheral artery disease (pad)

Conditions: Peripheral Arterial Disease; Iliac Artery Disease; Femoropopliteal Occlusive Disease; Below-the-knee Obstruction

Summary: the purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (optimed sinus superflex 635 or qualimed pontos-pp) or balloon angioplasty (cardionovum legflow or optimed nylotrack .035 + .018) according to current practice. the goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.


Eligibility criteria:
inclusion criteria: 1. patient must sign the informed consent form prior to the index-procedure. 2. patient is older than 18 years. 3. patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime. 4. patient suffers from mild to intermittent claudication (rutherford 1-3) or critical limb ischemia (rutherford 4-5). 5. target lesion is an occlusion or diameter stenosis is ≥50% by visual estimate. 6. target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (btk) arteries (anterior tibial artery, posterior tibial artery or peroneal artery). exclusion criteria: 1. patients with rutherford 0 and 6. 2. patient is pregnant. 3. patients with estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2. 4. patient has an acute thrombus or aneurysm in the target arteries. 5. patient has a life expectancy of \<12 months. 6. patient has a target lesion that cannot be crossed with a guidewire. 7. patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability. 8. patient has scheduled elective non-vascular procedures within 3 months after index-procedure. vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted. 9. contraindication for anti-thrombotic therapy (coagulopathy, ...). 10. patient has a known intolerance to anti-thrombotic medication or contrast agents.
combination of cryosurgery and nk immunotherapy for advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: the aim of this study is the safety and efficacy of cryosurgery plus nk immunotherapy to advanced nsclc.

by enrolling patients with nsclc adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (nk) cells for nsclc. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients withgrade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: non-small cell lung cancer cryosurgery nk immunotherapy
glut1: a novel tool re fl ecting proliferative activity of lung neuroendocrine tumors

Conditions: Lung Tumor

Summary: lung neuroendocrine tumor (lnt) represents approximately 20% of all lung cancers. the classification of lnt relies upon morphology. recently, in the world health organization (who) classification, ki-67 rate has been proposed for classi fication. it is, however, known that ki-67 count has a poor interlaboratory reproducibly. for that reason, our team has looked for a new biomarker. glut1 protein a facilitative glucose transporter protein which has ubiquitous expression in mammalian. glut1 is overexpressed in many human cancers. but, no study has evaluated the glut1 staining as an aid diagnosis in lnt. the team have assessed the glut1 immunohistochemical staining in 36 lnt and to assess its diagnostic value.

the (lnt) lung neuroendocrine tumor represents approximately 20% of all lung cancers. the classification of lnt relies upon morphology. recently, in the world health organization (who) classification, ki-67 rate has been proposed for classi fication. it is, however, known that ki-67 count has a poor interlaboratory reproducibly. for that reason, our team has looked for a new biomarker. glut1 protein a facilitative glucose transporter protein which has ubiquitous expression in mammalian. glut1 is overexpressed in many human cancers. but, no study has evaluated the glut1 staining as an aid diagnosis in lnt.

Eligibility criteria:
inclusion criteria: * patients with neuroendocrine tumors exclusion criteria: * patients without neuroendocrine tumors

Keywords: glut1 biomarkers diagnosis
predicting independent walking ability using the simplified stroke rehabilitation assessment of movement, berg balance scale, barthel index for activities of daily living in individuals post stroke

Conditions: Stroke

Summary: cohort observational retrospective pilot study by design. the purpose of this study was to determine a cut scores to predict independent ambulation for the simplified stroke rehabilitation assessment of movement, berg balance scale, barthel index for activities of daily living.


Eligibility criteria:
inclusion criteria: * male or female patients with stroke after the age of 17 confirmed stroke by neuroimaging, understanding instructions, time after stroke up to 1 year. exclusion criteria: * subjects were excluded if they have: the presence of aphasia that would have interfered with the participant's ability to understand and comply with study procedures or complete stroke assessments, dementia, ataxia, localization of stroke in the cerebellum or vertebrobasilar insufficiency, orthopedic problems that affected the ability to walk before the stroke and time after stroke more than 1 year.
a double-blind, placebo-controlled, single-dose study to evaluate the pk, im, and safety in japanese subjects

Conditions: Healthy Volunteers

Summary: a phase 1 randomized, double blind single-dose study to evaluate the pk and immunogenicity of single sc 100 and 150 mg doses of mavrilimumab in healthy adult japanese subjects.

this is a phase 1, randomized, double-blind, placebo-controlled, parallel group, single-dose study to evaluate the pk, immunogenicity, and safety of mavrilimumab at doses of 100 and 150 mg in healthy adult japanese subjects. the study will be conducted at one site in europe and subjects will be randomized in a 5:5:2 ratio to 100, 150mg mavrilimumab and placebo.

Eligibility criteria:
inclusion criteria: * subject is of japanese ethnicity * no evidence of clinically significant respiratory disease exclusion criteria: * any condition that, would interfere with the evaluation of the study drug or safety of subjects. * subject has a known hypersensitivity to any components of the investigational product. * history of infection requiring hospitalization or treatment with iv antibiotics within 12 weeks before screening, or evidence of clinically significant active infection. * subject has a history or present condition of malignancy. * subject has a history or presence of drug addiction (urine test) or has alcohol consumption (breath test) of more than 21 (males) or 14 (females) units of alcohol per week. * any blood donation or significant loss of blood within 56 days of study initiation, * receipt of live (attenuated) vaccine within the 4 weeks before screening or during the study.

Keywords: healthy volunteers, rheumatoid arthritis, mavrilimumab
an open-label study to investigate the absorption, metabolism and excretion of radiolabeled pd 0332334 in six healthy male volunteers

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to investigate the absorption, metabolism and excretion of \[14c\] pd 0332334 to characterize plasma, fecal and urinary radioactivity and identify any metabolites of \[14c\] pd 0332334.


Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. healthy male subjects between the ages of 18 and 55 years, inclusive. (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). 2. body mass index (bmi) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). 3. evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. 4. subjects who are willing and able to comply with scheduled confinement period, treatment plan, laboratory tests, and other trial procedures. exclusion criteria: subjects presenting with any of the following will not be included in the trial: 1. evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, orallergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). 2. subjects enrolled in a previous radionucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry. 3. subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
inactivated poliomyelitis vaccine made from sabin strain

Conditions: Poliomyelitis

Summary: this study includes both active and passive safety monitoring in large pupulations for the phase iv safety monitoring study of inactivated poliomyelitis vaccine made from sabin strain (sipv).

for active safety monitoring in expanding populations, a total of 20,019 participants in shanghai cdc have been enrolled in accordance with gcp for close safety monitoring for immediate adverse events and telephone or visiting follow-up (30 min, 24h, 3d, 7d, 14d, 30d) for passive safety monitoring in larger populations, the purpose is to observe rare adverse events after primary and booster immunization with sipv by passive safety surveillance via aefi monitoring system in shanghai cdc. a total of 29,712 infants have been enrolled, and the adverse events of the participates have been collected via aefi monitoring system and evaluated after 3-dose sipv for primary immunization.

Eligibility criteria:
inclusion criteria: * healthy infants of 2 months of age * the legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card). * guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation. * guardians are capable of using thermometer, graduated scale, filling diary card and contact card. * participants are not vaccinated with polio vaccine and immunoglobulin (except for hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment. * participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample. * axillary temperature ≤37℃ exclusion criteria: * allergic to any active substance, inactive substance or materials used during production such as kanamycin. * patients with fever or acute disease. * have thrombocytopenia or hemorrhagic diseases * patients undergoing immunosuppressive therapy or immunodeficiency * have uncontrolled epilepsy or other progressive neurological disorders * other situations that the investigator consider as non-eligible
prevention of parenteral nutrition-associated cholestasis with cyclic parenteral nutrition in infants

Conditions: Cholestasis; Prematurity; Gastroschisis; Intestinal Atresia; Necrotizing Enterocolitis

Summary: hypothesis to be tested: since the first description of intravenous alimentation over half a century ago, parenteral nutrition (pn) has become a common nutritional intervention for conditions characterized by inability to tolerate enteral feeds such as short bowel syndrome, chronic intestinal pseudoobstruction, microvillus inclusion disease, crohn's disease, multi-organ failure and prematurity. parenteral nutrition-associated liver disease (pnald) encompasses a spectrum of disease including cholestasis, hepatitis, steatosis and gallbladder sludge/stones which may progress to liver cirrhosis and even failure. there is a direct correlation between duration of parenteral nutrition and development of cholestasis in infants. there is evidence in animals and humans that cycling of parental nutrition, defined as infusing nutrients over a time period shorter than 24 hours, reduces cholestasis. there is also data that premature infants with gestational age (ga) \< 32 weeks and birth weight \<1500g, as well as infants with congenital anomalies of the gastrointestinal tract, are among those at highest risk of developing parenteral nutrition-associated cholestasis (pnac). we therefore hypothesize that infants with gestational age (ga) \<32 weeks and birth weight (bw) between \<1500g, or with congenital anomaly of the gastrointestinal tract regardless of ga or bw, receiving pn over a period of 20 hours will have a decrease severity of pnac, demonstrated by a lower peak direct bilirubin, compared to a similar control population receiving standard 24 hour infusion.


Eligibility criteria:
inclusion criteria: 1. infants expected to need prolonged pn (receiving \>75% pn on dol 7) with the following risk factors: 1. prematurity with gestational age (ga) \<32 weeks and birth weight \<1500g. or 2. congenital anomaly of the gastrointestinal tract regardless of ga or bw 2. screening direct bilirubin prior to the initiation of parenteral nutrition \<2mg/dl. exclusion criteria: 1. infants with major congenital anomalies, other than those of the gastrointestinal tract. 2. infants with known obstruction of the hepatobiliary tract. 3. infants with suspected congenital infection or suspected genetic/metabolic syndrome predisposing them to cholestasis based on direct bilirubin \> 2mg/dl prior to instituting pn.

Keywords: pnald pnac parenteral nutrition-associated cholestasis congenital anomalies of gastrointestinal tract
genomic dna in human blastocoele fluid

Conditions: Chromosomal Aneuploidies; Single Gene Desease

Summary: the objective will focus on the characterization of dna fragments present in blastocoele fluid, and the evaluation of these fragments as potential target for preimplantation genetic diagnosis. to reach this goal, real-time pcr, whole genome amplification techniques and -subsequently- next generation sequencing and acgh approaches will be used.


Eligibility criteria:
inclusion criteria: * ivf patient with supernumerary embryos to vitrify at blastocyst stage exclusion criteria: * ivf patient without blastocyst formation

Keywords: blastocoele fluid human dna molecular diagnosis
computer-aided prevention system

Conditions: Cerebrovascular Diseases; Stroke; Cardiovascular Diseases; CVD Risk Factors

Summary: stroke is one of the most frequent and life-threatening diseases in europe. about four stroke events occur per day in luxembourg alone, and about 30% of these patients are affected by recurrent stroke within the following five years. thus, new methods of primary and secondary prevention are needed to better control lifestyle-related risk factors. the development and maintenance of a healthy lifestyle (smoking cessation, healthy nutrition, moderate physical exercises etc.) is a major objective concerning the primary and secondary prevention of cerebro- and cardiovascular diseases. capsys is a computer-based lifestyle coaching system developed by researchers from the public research centre (crp) henri tudor in luxembourg in collaboration with neurologists from the centre hospitalier de luxembourg (chl), which aims at supporting patients in performing appropriate behavior changes in order to minimize their individual risk factors. patients can access capsys by dialing a local-rate telephone number and answer to a set of previously known questions concerning their current nutrition, physical activity, blood pressure, smoking etc. in an interactive voice response approach, questions are issued by the system in natural language using text-to-speech, and the patient can provide the required values using the phone keypad. based on the gathered values for each patient, the system automatically generates personalized verbal feedback at runtime and presents it to the patient during the phone dialog. depending on the individual development of the patient's risk factors, the system feedback can contain advice for improvement, praise for healthy behavior and motivation to pursue a certain goal. the user acceptance and effectiveness of the capsys system is evaluated in a six-month randomized controlled study with participants recruited at chl's neurology department.


Eligibility criteria:
inclusion criteria: * at high risk of stroke: * already suffered a stroke or transient ischemic attack (tia) or * at least two risk factors for stroke: * high blood pressure * overweight * low physical activity * smoking * unhealthy diet exclusion criteria: * inability to fill out or to understand the informed consent * no signed informed consent * dementia

Keywords: lifestyle coaching phone-based system cvd prevention patient-centered decision support
platelet-rich plasma for low back pain

Conditions: Discogenic Pain; Platelet-rich Plasma

Summary: this study aims to evaluate the effect of platelet-rich plasma (prp) on discogenic low back pain by comparing the pre- and post-interventional outcomes in patients receiving intradiscal injection of autologous prp.

intervertebral disc (ivd) degeneration is an important clinical problem that often contributes to low back pain and degenerative disc diseases. degeneration of the ivd induces anulus tears and fissures, which can cause severe discogenic low back pain. because the ivd has little potential to self-regenerate, treatment of degenerative disc disease is one of the most challenging clinical problems facing the spine surgeon. platelet-rich plasma (prp) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. because activated platelets have the potential to release growth factors, prp has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. the soluble releasate isolated from prp has recently been demonstrated to influence the metabolism of intervertebral discs in vitro. furthermore, an intradiscal injection of autologous prp has been shown to induce restoration of structural changes in the rabbit annular injection model in vivo. this clinical trial aims to investigate the safety and efficacy of intradiscal prp injection in patients with discogenic low back pain. the pre- and post-interventional imaging and clinical outcomes will be compared.

Eligibility criteria:
inclusion criteria: * age between 20 and 60 years * l-spine disc degeneration diagnosed by mri * low back pain exclusion criteria: * herniated disc * with prior history of spine surgery * with current or prior history of cancer * with current or prior history of hematological disease * pregnancy * patients who will not cooperate with one-year followup

Keywords: platelet-rich plasma intervertebral disc degeneration low back pain
early gestational diabetes mellitus

Conditions: Gestational Diabetes

Summary: in 2010, the international association of the diabetes and pregnancy study groups (iadpsg) panel published consensus-based recommendations on the diagnosis and classification of hyperglycemia in pregnancy. cognizant that milder degrees of hyperglycemia would also be detected by early pregnancy testing, the iadpsg recommended that fasting plasma glucose (fpg) in the range of 5.1-6.9 mmol/l should be considered diagnostic of early gestational diabetes mellitus (gdm) even if the level of proof for this recommendation is very low regarding to prognosis. this threshold was extrapolated from the fpg value used between 24 and 28 weeks. in france, a fpg is proposed at the first prenatal visit for women with risk factors of gdm. early gdm is diagnosed if fpg is ≥ 5.1 mmol/l, leading to an intensive metabolic management. data have shown that gdm prevalence increased rapidly from 5.9% in 2009 to 9.3% in 2014. 26.9% of women with hyperglycemia during their pregnancy but without known diabetes are treated before 22 weeks' gestation (wg). more recent data from italy and china, where iadpsg diagnosis criteria were applied, have strongly challenged this recommendation, and showed that early fpg ≥ 5.1mmo/l is poorly predictive of later gdm. no prior studies have demonstrated benefits to early screening and management. in 2016, the iadpsg members have suggested that the use of the fpg threshold ≥5.1 mmol/l for the identification of gdm in early pregnancy is not justified by current evidence


Eligibility criteria:
inclusion criteria: * pregnant woman * singleton pregnancy * early gdm defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with at least one risk factor (age ≥35 years and/or bmi ≥ 25 kg/m2 and/or familial history of diabetes and/or personal history of gdm and/or personal history of macrosomia). * first prenatal visit prior 20 weeks of gestation at the time of randomization. * signed informed consent exclusion criteria: diabetic follow-up started at time of inclusion * pre-existing diabetes in pregnancy * renal impairment * hepatic insufficiency * history of bariatric surgery * long time corticosteroids treatment * insufficient understanding * language difficulties * lack of social insurance * person in emergency situation * person under the protection of justice (tutelage/ curatorship) * persons deprived of their liberty

Keywords: early gestational diabetes pregnancy fasting plasma glucose diagnosis prognosis